Lipid levels fell significantly in people who switched from coformulated abacavir/lamivudine to tenofovir/emtricitabine (both with efavirenz) in a British multicenter randomized trial [1]. Study participants reported greater satisfaction with the new combination, given as the single pill Atripla, than with their starting regimen, given once daily as Kivexa (also called Epzicom) plus efavirenz.

Study participants were all taking a stable regimen of Kivexa plus efavirenz, all had a viral load below 50 copies for at least 6 months, and all had a total cholesterol reading of 200 mg/dL or more. The investigators randomized 79 people to switch immediately to Atripla and 78 to continue their current regimen for 12 weeks and then to switch. Of those 78 people, 73 made the 12-week trade.

The study groups were well matched in baseline traits, with a median age of 42 in the Atripla group and 44 in the Kivexa group. Median body mass index measured 25.7 kg/m(2) in the Atripla arm and 25.8 kg/m(2) in the Kivexa arm. Median fasting total cholesterol when the study began was 256 mg/dL in people assigned to Atripla and 239 mg/dL in those assigned to Kivexa. While 11% in the Atripla group had tried lipid-lowering therapy, 17% in the Kivexa group had used antilipid agents.

At the 24-week point, 7 people had dropped out of the Atripla arm, 3 because of adverse events. Five people quit in the Kivexa arm, 1 because of adverse events. There were no protocol-defined virologic failures during the 24-week study, and no drug-related serious adverse events.

Fasting lipid values improved significantly at weeks 12 and 24. In both study arms, marked improvements began as soon as Atripla started. Average changes from starting values at week 24 were -28 mg/dL for total cholesterol, -21 mg/dL for low-density lipoprotein cholesterol, and -26 mg/dL for triglycerides (P < 0.001 for all changes). The total-to-high-density lipoprotein cholesterol ratio did not change substantially through the 24 weeks. The Framingham cardiovascular risk score varied hardly at all during the study. Two measures of kidney function--creatinine clearance and estimated glomerular filtration rate--did not change meaningfully throughout the study.

A survey completed by study participants showed high satisfaction with Kivexa plus efavirenz, but better satisfaction with Atripla. At week 12, 91% taking Atripla reported being "very satisfied" with the 3-in-1 pill, compared with 77% "very satisfied" with Kivexa/efavirenz. While 81% were "very satisfied" with their ability to tolerate Atripla, 62% were "very satisfied" with tolerability of Kivexa/efavirenz. Ease of taking the regimen rose from 79% at baseline to 90% (P = 0.004).